Operating an infusion pump system

ABSTRACT

Some embodiments of an infusion pump system can be configured to control dispensation of medicine according to a closed-loop delivery mode that is responsive to feedback information provided from a monitoring device, and the infusion pump system permits a user to interrupt the closed-loop delivery mode for purposes of dispensing a user-selected manual bolus dosage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of and claims priority toU.S. application Ser. No. 15/848,622, filed on Dec. 20, 2017, now U.S.Pat. No. 10,603,433, issued Mar. 31, 2020, which is a continuationapplication of and claims priority to U.S. application Ser. No.14/699,341, filed on Apr. 29, 2015, now U.S. Pat. No. 9,878,097, issuedJan. 30, 2018.

TECHNICAL FIELD

This document relates to an infusion pump system, such as a portableinfusion pump system for dispensing insulin or another medicine.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.

Infusion pump devices often seek to deliver medicine in accuratelycontrolled dosages. Over-dosages and under-dosages of medicine can bedetrimental to patients. For example, an infusion pump device thatdelivers an over-dosage or under-dosage of insulin to a diabetes patientcan significantly affect the blood-glucose level of the patient.

Some insulin pump devices may control the dispensation of insulin usinga closed-loop controller in which the insulin dispensation isautomatically adjusted in response to sensor feedback indicative of auser's blood glucose level. For example, these pump devices that operateusing a closed-loop controller would subsequently increase the insulindispensation after detecting a rise in a user's blood glucose level(e.g., after the user has consumed a meal). Some of these closed-loopinsulin pump devices purport to act as an “artificial pancreas” in whichno user input is prompted when the controller adjusts the insulindispensation.

BRIEF SUMMARY

Some embodiments of an infusion pump system described herein can beconfigured to control the dispensation of medicine (e.g., insulin)according to an interruptible closed-loop delivery mode. During theclosed-loop delivery mode, the infusion pump system may autonomouslydispense medication to the user based on a sensed physiological state.For example, the infusion pump system may dispense insulin to a user inresponse to the user's blood glucose level while operating in aclosed-loop delivery mode. In some embodiments, the closed-loop deliverymode may be temporarily interrupted to accommodate a user-prompted bolusdosage. For example, the user may elect to manually enter a specificbolus dosage or to initiate the calculation of a suggested bolus dosageby accessing a user interface of the infusion pump system. Optionally,the infusion pump system is configured to perform one or more dosagecalculations for purposes of providing the user-prompted bolus dosage.Such a bolus dosage calculation may account for medication dispensedduring operations in the closed-loop delivery mode over a predeterminedtime period immediately prior to the calculation. Thus, in someembodiments, the infusion pump system is configured to calculate theamount of effective insulin-on-board (eIOB), which corresponds to thenet amount of remaining active insulin in the user's system from dosagesduring the predetermined time period.

Particular embodiments described herein include a method of operating aportable insulin infusion pump system. The method may include detectinga trigger event to initiate a user-selected manual bolus dosage whileoperating an infusion pump system to dispense insulin according to aclosed-loop delivery mode. The method may further include temporarilyinterrupting the closed-loop delivery mode by dispensing from theinfusion pump system the user-selected manual bolus dosage. Also, themethod may include automatically returning to the closed-loop deliverymode after dispensation of the user-selected manual bolus dosage. Acalculated dosage amount of the user-selected manual bolus dosage may becalculated by the infusion pump system based upon at least both userinput of a particular value(s) and a calculated amount of insulinpreviously dispensed during the closed-loop delivery mode over a timeperiod immediately prior to interruption of the closed-loop deliverymode.

In some embodiments, a method of operating a portable insulin infusionpump system may include detecting a trigger event to initiate auser-selected manual bolus dosage while operating an infusion pumpsystem to dispense insulin according to a closed-loop delivery mode. Themethod may also include determining, at the infusion pump system, thatthe user-selected manual bolus dosage is permissible based on (at least)an amount of the bolus dosage and a calculated amount of insulinpreviously dispensed during the closed-loop delivery mode over a timeperiod immediately prior to the trigger event. The method may furtherinclude initiating delivery of the permissible bolus dosage.

In certain embodiments, a method of operating a portable insulininfusion pump system may include detecting a trigger event to initiate auser-selected manual bolus dosage while operating an infusion pumpsystem to dispense insulin according to a closed-loop delivery mode inwhich insulin is dispensed in response to feedback information of auser's blood glucose characteristic. Optionally, the method may furtherinclude temporarily interrupting the closed-loop delivery mode bydispensing from the infusion pump system the user-selected manual bolusdosage. Also, the method may include automatically returning to theclosed-loop delivery mode after dispensation of the user-selected manualbolus dosage.

According to one or more embodiments, the closed-loop delivery modecauses the infusion pump system to dispense insulin in response tofeedback information of a user's blood glucose level, and the triggerevent includes actuation of a user interface button indicating a user'srequest to manually initiate a bolus dispensation that is independentfrom the feedback information of the user's blood glucosecharacteristic. According to one or more embodiments, the user-selectedmanual bolus dosage is dispensed independently of the feedbackinformation of the user's blood glucose characteristic.

According to one or more embodiments, the trigger event includesactuation of a user interface button indicating a user's request toinitiate calculation of a suggested bolus dosage by the infusion pumpsystem.

According to one or more embodiments, the infusion pump system includesa controller, which may optionally comprise a user interface displaydevice and control circuitry arranged in a controller housing and beingprogrammed to perform the calculation of the manual bolus dosage.According to one or more embodiments, the infusion pump system may alsoinclude a pump device, which may optionally comprise a pump housing thathouses a drive system and a space to receive a medicine (e.g., insulinin particular implementations). Also, in some embodiments, thecontroller housing may be removably mountable to the pump housing sothat the controller is electrically connected to components of the pumpdevice (e.g., the drive system, other components, or a combinationthereof).

According to one or more embodiments, the amount of insulin dispensedduring the closed-loop delivery mode over the time period includes aneffective-insulin-on-board amount calculated as follows:Effective Insulin-on-Board=[Σ(Dosage_(n)*DurationFactor(t)_(n))]−Estimated Basal Rate,

where n is any positive whole number, and where Duration Factor(t)_(n),represents a factor discounting the dosage based on an amount of time(t) since its delivery.

According to one or more embodiments, the method further includesoutputting an alert from the infusion pump system in response to acalculated stacking value exceeding a predetermined stacking threshold,the calculated stacking value includes the calculated dosage amount ofthe user-selected manual bolus dosage plus the EffectiveInsulin-on-board. According to one or more embodiments, the calculateddosage amount of the user-selected manual bolus dosage includes includea calculation of a suggested bolus dosage according to the followingfunction:Suggested Bolus Dosage=(Food Offsetting Component)+(Blood GlucoseCorrection Component)−(Effective Insulin-on-board Component).

According to one or more embodiments, the Estimated Basal Rate iscalculated according to the following function:Estimated Basal Rate=Total Dose/(T*Scale Down Factor), where T is a unitof time.

Particular embodiments described herein include a medical infusion pumpsystem, which may be (optionally) configured as a wearable pump systemto dispense insulin or another medicine to a user. The system mayinclude a portable pump housing configured to receive medicine fordispensation to a user. The pump housing may at least partially containa pump drive system to dispense the medicine through a flow path to theuser. The system may also include a controller that controls the pumpdrive system to dispense the medicine from the portable pump housingaccording to a closed-loop delivery mode in which, for example, thecontroller autonomously provides insulin dosages to the user in responseto feedback information of a user's blood glucose level. The controllermay be configured to, in response to receiving input indicative of auser-prompted bolus dosage, temporarily interrupt the closed-loopdelivery mode by dispensing from the infusion pump system theuser-prompted bolus dosage. The calculated dosage amount of theuser-prompted bolus dosage is calculated by the infusion pump systembased upon both user input of a particular value(s) and a calculatedamount of insulin previously dispensed during the closed-loop deliverymode over a predetermined time period prior to the user-prompted bolusdosage.

According to one or more embodiments, the input indicative of theuser-prompted bolus dosage includes actuation of a user interface buttonindicating a user request to manually enter a bolus dosage amount.

According to one or more embodiments, the input indicative of theuser-prompted bolus dosage includes actuation of a user interface buttonindicating a user request to initiate a calculation, by the infusionpump system, of a suggested bolus dosage.

According to one or more embodiments, the controller includes a userinterface including a display device and a plurality of buttons.According to one or more embodiments, the controller includes acontroller housing that removably attaches to the pump housing.According to one or more embodiments, the controller is electricallyconnected to the pump drive system when the controller housing isremovably attached to the pump housing. According to one or moreembodiments, the controller is a reusable device and the pump housingand pump drive system are disposable and nonreusable (e.g., one or morestructural components of the pump device that hinder reuse of the pumpdevice after exhaustion of the medicine supply in the pump device).

According to one or more embodiments, the system further includes amonitoring device that communicates glucose information to thecontroller, the glucose information being indicative of a blood glucoselevel of the user.

Certain embodiments described herein include a portable infusion pumpsystem, which may include a portable pump housing that defines a spaceto receive medicine for dispensation to a user. The pump housing may atleast partially house a pump drive system to dispense the medicinethrough a flow path to the user. The system may also include controlcircuitry that controls the pump drive system to dispense the medicinefrom the portable pump housing according to a closed-loop delivery modein which insulin is dispensed, for example, at differing rates inresponse to feedback information of a user's blood glucosecharacteristic. The system may further include a user interface incommunication with the control circuitry and being configured to receiveuser input to interrupt the closed-loop delivery mode. The controlcircuitry may be configured to temporarily interrupt the closed-loopdelivery mode by dispensing from the infusion pump system auser-selected manual bolus dosage. Optionally, the control circuitry maybe configured to automatically restart the closed-loop delivery modeafter dispensation of the user-selected manual bolus dosage (or may beconfigured to automatically prompt the user to confirm (via a userinterface display) the restarting the closed-loop delivery mode afterdispensation of the user-selected manual bolus dosage).

Some or all of the embodiments described herein may provide one or moreof the following advantages. First, some embodiments of the infusionpump system described herein can include a portable design that isconfigured to be conveniently worn by user (e.g., on the user's skin orin a pocket) while operating in closed-loop delivery mode so as toautomatically adjust insulin dispensation to a user in response to theuser's blood glucose level (or other physiological state).

Second, some embodiments of the infusion pump system may dispenseinsulin to a user in response to the user's blood glucose level whileoperating in a closed-loop delivery mode, yet the user can convenientlyinterrupt the closed-loop delivery mode for purposes of demandingmanually-initiated bolus dosage. Such interruption of the closed-loopdelivery mode may be a temporary interruption, for example, when thecontroller is configured to automatically return to the closed loopdelivery mode after dispensation of the manually-initiated bolus dosage(without intervention from the user). Accordingly, the user can wear theinfusion pump system that operates according to the closed-loop deliverymode throughout the day, but the user can briefly interrupt theclosed-loop delivery mode to manually initiate a “meal bolus” (or othertype of bolus) prior to consuming a meal. For example, the user mayelect to manually enter a specific bolus dosage or to initiate thecalculation of a suggested bolus dosage based upon user input of anestimated number of carbohydrates to be consumed. Because the user canmanually initiate the user-prompted bolus dosage prior to consuming themeal (e.g., before the user's blood glucose level rises due to consumingthe food), the user may not experience a significant rise in his or herblood glucose level that might otherwise occur if operating underclosed-loop control. After the manually-initiated bolus dosage isdispensed to the user, the infusion pump system can be configured toautomatically return to the closed-loop delivery mode.

Fourth, in some embodiments described herein, the infusion pump systemcan be configured to calculate a dosage amount for themanually-initiated bolus dosage that accounts not only for the userinput (e.g., of an estimated number of carbohydrates or otherparameters), but also accounts for the insulin that was previouslydispensed (during the closed-loop delivery mode) but has not yet actedin the user's body. For example, the infusion pump system can determinea calculated dosage amount for the manually-initiated bolus dosage basedupon both user input and an amount of insulin dispensed during theclosed-loop delivery mode over a time period prior to the user-promptedbolus dosage. In doing so, some implementations of the infusion pumpsystem may calculate the eIOB, which corresponds to the net amount ofremaining active insulin in the user's system from dosages during thepredetermined time period (e.g., including the various insulindispensations that occurred during the closed-loop delivery mode).

Fifth, some embodiments of the infusion pump system may provide anadditional level of safety to prevent an overdose of medicine resultingfrom a manually-initiated bolus dosage that interrupts a closed-loopdelivery mode. For example, the infusion pump system may be configuredto calculate a stacking value in response to receipt of a manuallyentered bolus dosage requested by the user. The stacking value mayrepresent the amount of insulin that would be active in the user's bodyif the requested dosage were dispensed. If the stacking value exceeds apredetermined stacking threshold, the infusion pump system may attemptto prevent an overdose of the insulin by one or more of the followingoperations: alerting the user to the amount of eIOB, preventingdispensation of the requested dosage, and prompting the user to select acorrected dosage. The stacking value may be calculated by aggregatingthe requested bolus dosage with the eIOB. Similarly, in someembodiments, the amount of eIOB can be accounted for in the calculationof a suggested bolus dosage prompted by the user. As another example,the infusion pump system may be configured to calculate a predictedfuture blood glucose level in response to receipt of a manually enteredbolus dosage requested by the user. The future blood glucose level mayrepresent a blood glucose level that is predicted to occur in the user'sbody as a result of the requested bolus dosage. If future blood glucoselevel falls below a predetermined minimum blood glucose level (e.g., ablood glucose level below which the user is likely to suffer symptoms ofhypoglycemia, such as about 60 to 70 mg/dL in some cases), the infusionpump system may attempt to prevent an overdose of the insulin by one ormore of the above-recited operations. The future blood glucose level maybe calculated as the product of the stacking value and the user'sinsulin sensitivity.

Sixth, some embodiments of the infusion pump system can facilitate thecontrolled dispensation of both insulin and glucagon. For example, theinfusion pump system may provide a suggested glucagon dosage based onone or more particular parameters (e.g., the user's recent blood glucosecharacteristics, food intake data, an amount of insulin and/or glucagonalready delivered to the user which has not yet acted on the user,glucagon sensitivity of the user, and the like). The suggested glucagondosage may be dispensed directly from the infusion pump device ormanually injected via a suitable applicator (e.g., an injection pen). Insome circumstances, a controller device of the infusion pump system canreceive information indicative of the user's blood glucose level andsuggest a glucagon dosage that is at least partially dependent upon astored glucagon sensitivity value that is predetermined for the user.Such a glucagon dosage suggestion feature can be initiated, for example,by the infusion pump system in response to input of a blood glucoselevel that is below a target level, or in response to a predicted futurelow glucose event. In some implementations, the controller device mayinterrupt a closed-loop delivery mode to provide the suggested glucagondosage, or, alternatively, facilitate the glucagon dosage “on top” ofthe closed-loop operations.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a first example infusion pump system, inaccordance with some embodiments.

FIG. 2 is an exploded perspective view of a portion of the infusion pumpsystem of FIG. 1.

FIG. 3 is an exploded perspective view of a controller device for theinfusion pump system of FIG. 1.

FIG. 4A is a perspective view of the infusion pump system of FIG. 1including a user interface display for inputting a manual bolus dosage,in accordance with some embodiments.

FIG. 4B is a perspective view of the infusion pump system of FIG. 1including a user interface display for outputting an alert indicating amanual bolus dosage is not permitted.

FIG. 4C is a perspective view of the infusion pump system of FIG. 1including a user interface display for providing menu options to correctthe non-permitted manual bolus dosage.

FIG. 5 is a flowchart of an example process for operating an infusionpump system an interruptible closed-loop mode of control, in accordancewith some embodiments.

FIG. 6A is a flowchart of a first example process for temporarilyinterrupting a closed-loop delivery mode for providing amanually-initiated bolus dosage, in accordance with some embodiments.

FIG. 6B is a flowchart of a second example process for temporarilyinterrupting a closed-loop delivery mode for providing amanually-initiated bolus dosage, in accordance with some embodiments.

FIG. 7 is a perspective view of a second example infusion pump system,in accordance with some embodiments.

Like reference symbols in the various drawings may indicate likeelements.

DETAILED DESCRIPTION

Referring to FIG. 1, some embodiments of an infusion pump system 1 caninclude a pump assembly 10 featuring a pump device 100 and a controllerdevice 200. Optionally, the controller device 200 can be configured toreleasably attach with the pump device 100. The controller device 200can electrically communicate with the pump device 100 to control a drivesystem housed in the pump device 100 to dispense a medicine to a user(e.g., through a tube 147 of an infusion set 146 in this example). Whenthe controller device 200 and the pump device 100 are assembledtogether, the user can (in some embodiments) conveniently wear theinfusion pump system 1 on the user's skin under clothing, in a pouchclipped at the waist, or in the user's pocket while receiving the fluiddispensed from the pump device 100.

Briefly, in use, the pump device 100 in this embodiment is configured toremovably attach to the controller device 200 in a manner that providesa secure fitting, an overall compact size, and a reliable electricalconnection. For example, as described in more detail below in connectionwith FIG. 2, the controller device 200 can include a housing 210 havinga number of features that mate with complementary features of the pumphousing structure 110. In such circumstances, the controller device 200can removably attach with the pump device 100 in a generallyside-by-side configuration. The compact size permits the pump assembly10 to be discrete and portable. The controller device 200 can receiveuser input for purposes of operating the infusion pump system 1. In someembodiments, as described further below in connection with FIGS. 4A-6B,the infusion pump system 1 can be configured (e.g., appropriatelydesigned and programmed) to operate in a closed-loop delivery mode inwhich the controller device 200 operates the pump device 100 to dispenseinsulin to a user autonomously (e.g., without user interaction) based ona sensed physiological condition of the user. Optionally, theclosed-loop delivery mode can be temporarily interrupted by the user toprovide a manually-initiated bolus dosage (e.g., not an autonomousadjustment of the insulin dispensation). Preferably, the controllerdevice 200 may automatically return to the closed-loop delivery modefollowing completion or termination of the manually-initiated bolusdosage. Once resumed, future operations of the closed-loop delivery modecan account for any insulin dispensed during the manually-initiatedbolus dosage.

Still referring to FIG. 1, the infusion pump system 1 may optionallyinclude a glucose monitoring device 50 in communication with the pumpassembly 10 for the purpose of supplying data indicative of a user'sblood glucose level to the controller device 200. In some embodiments,as described further below in connection with FIG. 5, the controllerdevice 200 can utilize the data indicative of a user's blood glucoselevel during operations in the closed-loop delivery mode so as toautonomously adjust the insulin dispensation rate. The glucosemonitoring device 50 can include a housing 52, a wireless communicationdevice 54, and a sensor shaft 56. The wireless communication device 54can be contained within the housing 52 and the sensor shaft 56 canextend outward from the housing 52. In use, the sensor shaft 56 canpenetrate the skin 20 of a user to make measurements indicative ofcharacteristics of the user's blood (e.g., the user's blood glucoselevel or the like). In response to the measurements made by the sensorshaft 56, the glucose monitoring device 50 can employ the wirelesscommunication device 54 to transmit data to a corresponding wirelesscommunication device 247 housed in the pump assembly 10. In someembodiments, the monitoring device 50 may include a circuit that permitssensor signals (e.g., data from the sensor shaft 56) to be communicatedto the communication device 54. The communication device 54 can transferthe collected data to the controller device 200 (e.g., by wirelesscommunication to the communication device 247). Alternatively, themonitoring device 50 can employ other suitable methods of obtaininginformation indicative of a user's blood characteristics andtransferring that information to the controller device 200. For example,an alternative monitoring device may employ a micropore system in whicha laser porator creates tiny holes in the uppermost layer of a user'sskin, through which interstitial glucose is measured using a patch. Inthe alternative, the monitoring device can use iontophoretic methods tonon-invasively extract interstitial glucose for measurement. In otherexamples, the monitoring device can include non-invasive detectionsystems that employ near IR, ultrasound or spectroscopy, and particularembodiments of glucose-sensing contact lenses. Invasive methodsinvolving optical means of measuring glucose could also be added. In yetanother example, the monitoring device can include an optical detectioninstrument that is inserted through the skin for measuring the user'sglucose level.

Furthermore, it should be understood that in some alternativeembodiments, the monitoring device 50 can be in communication with thecontroller device 200 via a wired connection. In other embodiments ofthe infusion pump system 1, one or more test strips (e.g., blood teststrips) containing a sample of the user's blood can be inserted into astrip reader portion of the infusion pump system 1 to be tested forcharacteristics of the user's blood. Alternatively, the test strips(e.g., glucose test strips) containing a sample of the user's blood canbe inserted into a glucose meter device (not shown in FIG. 1), whichthen analyzes the characteristics of the user's blood and communicatesthe information (via a wired or wireless connection) to the controllerdevice 200. In still other embodiments, characteristics of the user'sblood glucose information can be entered directly into the pump assembly10 via a user interface 220 on the controller device 200.

Referring now to FIG. 2, the pump device 100 in this embodiment includesa housing structure 110 that defines a cavity 116 in which a fluidcartridge 120 can be received. The pump device 100 also can include acap device 130 to retain the fluid cartridge 120 in the cavity 116 ofthe housing structure 110. The pump device 100 can include a drivesystem (not shown) that advances a plunger 125 in the fluid cartridge120 so as to dispense fluid therefrom. In this embodiment, thecontroller device 200 communicates with the pump device 100 to controlthe operation of the drive system. Optionally, the controller device 200may be configured as a reusable component that provides electronics anda user interface to control the operation of the pump device 100. Insuch circumstances, the pump device 100 can be a disposable componentthat is disposed of after a single use. For example, the pump device 100can be a “one time use” component that is thrown away after the fluidcartridge 120 therein is exhausted. Thereafter, the user can removablyattach a new pump device (having a new fluid cartridge) to the reusablecontroller device 200 for the dispensation of fluid from a new fluidcartridge. Accordingly, the user is permitted to reuse the controllerdevice 200 (which may include complex or valuable electronics, as wellas a rechargeable battery) while disposing of the relatively low-costpump device 100 after each use. Such a pump assembly 10 can provideenhanced user safety as a new pump device (and drive system therein) isemployed with each new fluid cartridge.

The pump assembly 10 can be a medical infusion pump assembly that isconfigured to controllably dispense a medicine from the cartridge 120.As such, the fluid cartridge 120 can contain a medicine 126 to beinfused into the tissue or vasculature of a targeted individual, such asa human or animal patient. For example, the pump device 100 can beadapted to receive a fluid cartridge 120 in the form of a carpule thatis preloaded with insulin or another medicine for use in the treatmentof Diabetes (e.g., BYETTA®, SYMLIN®, or others). Such a cartridge 120may be supplied, for example, by Eli Lilly and Co. of Indianapolis, Ind.Other examples of medicines that can be contained in the fluid cartridge120 include: pain relief drugs, hormone therapy, blood pressuretreatments, anti-emetics, osteoporosis treatments, or other injectablemedicines. The fluid cartridge 120 may have other configurations. Forexample, the fluid cartridge 120 may comprise a reservoir that isintegral with the pump housing structure 110 (e.g., the fluid cartridge120 can be defined by one or more walls of the pump housing structure110 that surround a plunger to define a reservoir in which the medicineis injected or otherwise received).

In some embodiments, the pump device 100 can include one or morestructures that interfere with the removal of the fluid cartridge 120after the fluid cartridge 120 is inserted into the cavity 116. Forexample, the pump housing structure 110 can include one or more retainerwings (not shown) that at least partially extend into the cavity 116 toengage a portion of the fluid cartridge 120 when the fluid cartridge 120is installed therein. Such a configuration may facilitate the“one-time-use” feature of the pump device 100. In some embodiments, theretainer wings can interfere with attempts to remove the fluid cartridge120 from the pump device 100, thus ensuring that the pump device 100will be discarded along with the fluid cartridge 120 after the fluidcartridge 120 is emptied, expired, or otherwise exhausted. In anotherexample, the cap device 130 can be configured to irreversibly attach tothe pump housing structure 110 so as to cover the opening of the cavity116. For example, a head structure of the cap device 130 can beconfigured to turn so as to threadably engage the cap device 130 with amating structure along an inner wall of the cavity 116, but the headstructure may prevent the cap device from turning in the reversedirection so as to disengage the threads. Accordingly, the pump device100 can operate in a tamper-resistant and safe manner because the pumpdevice 100 can be designed with a predetermined life expectancy (e.g.,the “one-time-use” feature in which the pump device is discarded afterthe fluid cartridge 120 is emptied, expired, or otherwise exhausted).

Still referring to FIG. 2, the controller device 200 can be removablyattached to the pump device 100 so that the two components aremechanically mounted to one another in a fixed relationship. In someembodiments, such a mechanical mounting can also form an electricalconnection between the removable controller device 200 and the pumpdevice 100. For example, the controller device 200 can be in electricalcommunication with a portion of the drive system (show shown) of thepump device 100. In some embodiments, the pump device 100 can include adrive system that causes controlled dispensation of the medicine orother fluid from the cartridge 120. In some embodiments, the drivesystem incrementally advances a piston rod (not shown) longitudinallyinto the cartridge 120 so that the fluid is forced out of an output end122. A septum 121 at the output end 122 of the fluid cartridge 120 canbe pierced to permit fluid outflow when the cap device 130 is connectedto the pump housing structure 110. For example, the cap device 130 mayinclude a penetration needle that punctures the septum 121 duringattachment of the cap device to the housing structure 110. Thus, whenthe pump device 100 and the controller device 200 are mechanicallyattached and thereby electrically connected, the controller device 200communicates electronic control signals via a hardwire-connection (e.g.,electrical contacts or the like) to the drive system or other componentsof the pump device 100. In response to the electrical control signalsfrom the controller device 200, the drive system of the pump device 100causes medicine to incrementally dispense from the fluid cartridge 120.Power signals, such as signals from a battery (not shown) of thecontroller device 200 and from the power source (not shown) of the pumpdevice 100, may also be passed between the controller device 200 and thepump device 100.

The controller device 200 can include a user interface 220 that permitsa user to monitor and actively control the operation of the pump device100. In some embodiments, the user interface 220 can include a displaydevice 222 and one or more user-selectable buttons (e.g., severalbuttons 224 are shown in the embodiment of FIGS. 1-2). The displaydevice 222 can include an active area in which numerals, text, symbols,images, or a combination thereof can be displayed. For example, thedisplay device 222 can be used to communicate a number of settings ormenu options for the infusion pump system 1 (FIG. 1). In thisembodiment, the user may press one or more of the buttons to shufflethrough a number of menus or program screens that show particularoperational modes (e.g., closed-loop delivery mode and, optionally, anopen-loop delivery mode in which a basal profile is implemented and thensupplemented with user-selected bolus dosages), settings (e.g., dosageparameters) and data (e.g., review data that shows a medicine dispensingrate, a total amount of medicine dispensed in a given time period, anamount of medicine scheduled to be dispensed at a particular time ordate, an approximate amount of medicine remaining in the cartridge 120,or the like). In some embodiments, the user can adjust the modes and/orsettings, or otherwise program the controller device 200 by pressing oneor more buttons 224 of the user interface 220. For example, the user maypress one or more of the buttons to temporarily change the operation ofthe infusion pump system 1 from a closed-loop delivery mode to provideat least one manually-initiated bolus dosage. In some implementations,the display device 222 may also be used to communicate informationregarding remaining battery life.

The controller device 200 can also be equipped with an inspection lightdevice 230. The inspection light device 230 can provide the user with atool to illuminate and inspect a targeted location. For example, theinspection light device 230 can be directed at the infusion site on theuser's skin to verify that the infusion set is properly embedded, or theinspection light device 230 can be directed at the pump device 100 toilluminate the cavity 116 or other areas. The inspection light device230 can also be used to notify the user to an alert condition of thepump assembly 10. For example, as described in more detail below, theinspection light device 230 can be activated when the controller hasdetected a possible problem with the infusion set 146. An activation ofthe inspection light device 230 can thereby provide a visualnotification (as an alternative to, or in addition to, the visualnotification provided on the display device 222) to the user thatattention to the pump assembly 10 is warranted.

The pump assembly 10 can be configured to be portable and can bewearable and concealable. For example, a user can conveniently wear thepump assembly 10 on the user's skin (e.g., skin adhesive) underneath theuser's clothing or carry the pump device 100 in the user's pocket (orother portable location) while receiving the medicine dispensed from thepump device 100. The pump assembly 10 is depicted in FIG. 1 as beingheld in a user's hand 5 so as to illustrate its size in accordance withsome embodiments. This embodiment of the pump assembly 10 is compact sothat the user can wear the portable pump assembly 10 (e.g., in theuser's pocket, connected to a belt clip, adhered to the user's skin, orthe like) without the need for carrying and operating a separate module.In such embodiments, the cap device 130 of the pump device 100 can beconfigured to mate with an infusion set 146. As shown in FIG. 1, theinfusion set 146 can be a tubing system that connects the pump assembly10 to the tissue or vasculature of the user (e.g., to deliver medicineinto the tissue or vasculature under the user's skin). The infusion set146 can include a flexible tube 147 that extends from the pump device100 to a subcutaneous cannula 149 that may be retained by a skinadhesive patch (not shown) that secures the subcutaneous cannula 149 tothe infusion site on the user's skin 20. The skin adhesive patch canretain the infusion cannula 149 in fluid communication with the tissueor vasculature of the user so that the medicine dispensed through thetube 147 passes through the cannula 149 and into the user's body. Thecap device 130 can provide fluid communication between the output end122 (FIG. 2) of the fluid cartridge 120 and the tube 147 of the infusionset 146.

In some embodiments, the pump assembly 10 can be pocket-sized so thatthe pump device 100 and controller device 200 can be worn in the user'spocket or in another portion of the user's clothing. In somecircumstances, the user may desire to wear the pump assembly 10 in amore discrete manner. Accordingly, the user can pass the tube 147 fromthe pocket, under the user's clothing, and to the infusion site wherethe adhesive patch can be positioned. As such, the pump assembly 10 canbe used to deliver medicine to the tissues or vasculature of the user ina portable, concealable, and discrete manner.

In some embodiments, the pump assembly 10 can be configured to adhere tothe user's skin directly at the location in which the skin is penetratedfor medicine infusion. For example, a rear surface of the pump device100 can include a skin adhesive patch so that the pump device 100 can bephysically adhered to the skin of the user at a particular location. Inthese embodiments, the cap device 130 can have a configuration in whichmedicine passes directly from the cap device 130 into an infusioncannula 149 that is penetrated into the user's skin. In some examples,the user can temporarily detach the controller device 200 (while thepump device 100 remains adhered to the skin) so as to view and interactwith the user interface 220.

Referring now to FIG. 3, the controller device 200 (shown in an explodedview) houses a number of components that can be reused with a series ofsuccessive pump devices 100. In particular, the controller device 200can include control circuitry 240 and a rechargeable battery pack 245,each arranged in the controller housing 210. The rechargeable batterypack 245 may provide electrical energy to components of the controlcircuitry 240, other components of the controller device (e.g., thedisplay device 222 and other user interface components, sensors, or thelike), and/or to components of the pump device 100. The controlcircuitry 240 may be configured to communicate control or power signalsto the drive system of the pump device 100, or to receive power orfeedback signals from the pump device 100.

The control circuitry 240 of the controller device 200 can include oneor more microprocessors 241 configured to execute computer-readableinstructions stored on one or more memory devices 242 so as to achieveany of the control operations described herein. For example, at least onmemory device 242 of the control circuitry 240 may be configured tostore computer-readable instructions for operating the pump device 100according to a closed-loop delivery mode and an open-loop delivery mode.

In the closed-loop delivery mode, the control circuitry 240 of thecontroller device 200 can operate the pump device 100 to autonomouslyalter the dispensation of insulin to a user based upon a sensedphysiological condition of the user. For example, if the infusion pumpsystem is dispensing insulin, closed-loop operations facilitated by thecontrol circuitry may cause the infusion pump system to imitate apancreatic beta cell so that the insulin dispensation is adjustedaccording to increases or decreases in the user's blood glucose level(see FIG. 5). This type of closed-loop control can be executed by thecontrol circuitry via any suitable control algorithm (e.g., aproportional-integral-derivative (PID), fuzzy logic, or model predictivecontrol algorithm). For example, U.S. Pat. No. 8,548,544 providesvarious examples of suitable closed-loop techniques involving fuzzylogic and predictive models for automated insulin dispensation.

Additionally, as described herein, even when the controller device 200is operating in the closed-loop delivery mode, the user can choose totemporarily interrupt the closed-loop delivery mode for purposes ofdemanding manually-initiated bolus dosage. In such circumstances, theuser can advantageously wear the infusion pump system 1 that operatesaccording to the closed-loop delivery mode throughout the day, but theuser can briefly interrupt the closed-loop delivery mode to manuallyinitiate a “meal bolus” (or other type of bolus). For example, the usercan trigger (via the user interface 220) an interruption of theclosed-loop delivery mode, so that the user can manually enter aspecific bolus dosage or initiate the calculation of a suggested bolusdosage based upon user input of an estimated number of carbohydrates tobe consumed. Because the user can manually initiate the user-promptedbolus dosage prior to consuming the meal (e.g., before the user's bloodglucose level rises due to consuming the food), the user may notexperience a significant rise in his or her blood glucose level thatmight otherwise occur if operating under closed-loop control. After themanually-initiated bolus dosage is dispensed to the user, the infusionpump system can be configured to automatically return to the closed-loopdelivery mode.

In the open-loop delivery mode, the control circuitry 240 of thecontroller device 200 can operate the pump device 100 to deliver insulinto the user according to a basal rate profile and user-selected bolusdosages. The user may select one or more bolus deliveries, for example,to offset the blood glucose effects caused by food intake, to correctfor an undesirably high blood glucose level, to correct for a rapidlyincreasing blood glucose level, or the like. In some examples, the bolusdosages can be determined based on calculations made by the controllerdevice 200 in response to a request by the user. For example, when theuser's blood glucose level is rapidly increasing and has reached a highlevel (e.g., as indicated by the data received from the glucosemonitoring device 50), the user may request the controller device 200 tocalculate an appropriate bolus dosage of insulin to correct for therapid increase and elevated blood glucose level. In another example, theuser can request (via the user interface 220) that the controller device200 calculate and suggest a bolus dosage based, at least in part, on aproposed meal that the user plans to consume.

The insulin dispensed into the user's body during closed-loop deliverymode and during any manually-initiated bolus dosages may act over aperiod of time to control the user's blood glucose level. As such, theuser can benefit from the embodiments of the infusion pump system 1 thatcan take into account different circumstances and information whendetermining a dosage amount. For example, when calculating an insulindosage, the controller device 200 employed one or more user-specificdosage parameters that reflect the user's physiological response toinsulin. In some embodiments, the controller device 200 can employ theuser-specific dosage parameters in combination with data indicative ofthe user's blood glucose level, historical food intake data previouslysubmitted by the user, the user's insulin load, and the like to providean accurate dosage calculation. Exemplary information that can bederived from the user's blood glucose information that can be used bythe controller device 200 in determining a bolus dosage can include theuser's current blood glucose level, the rate of change in the user'sblood glucose level, the 2nd derivative of the user's blood glucosedata, the shape and/or appearance of the user's blood glucose curve, orthe like. In some embodiments, the controller device 200 can useinformation from previously entered meals and previously deliveredinsulin dosages when calculating a suggested bolus dosage. In theseembodiments, information regarding previously entered meals andpreviously delivered insulin dosages from 12 hours or more (e.g., 24hours, 12 hours, 8 hours, 6 hours, 0.5 hours, or the like) can be usedin the bolus dosage calculations.

Relevant user-specific dosage parameters may include, but are notlimited to, one or more of the following: insulin sensitivity (e.g., inunits of mg/dL/insulin unit), carbohydrate ratio (e.g., in units ofg/insulin unit), insulin onset time (e.g., in units of minutes and/orseconds), insulin-on-board duration (e.g., in units of minutes and/orseconds), and basal rate profile (e.g., an average basal rate or one ormore segments of a basal rate profile expressed in units of insulinunit/hour). These and other suitable dosage parameters may be pre-loadedinto the control circuitry 240 or input by a user via the userinterface. Further, in some examples, the control circuitry 240 cancause the memory device 242 to store any of the following parametersderived from the historical pump usage information: dosage logs, averagetotal daily dose, average total user-initiated bolus dose per day, aratio of correction bolus amount per day to food bolus amount per day,amount of correction boluses per day, a ratio of a correction bolusamount per day to the average total daily dose, average maximum bolusper day, and a frequency of cannula and tube primes per day. To theextent these aforementioned dosage parameters or historical parametersare not stored in the memory device 242, the control circuitry 240 canbe configured to calculate any of these aforementioned dosage parametersor historical parameters from other data stored in the memory device 242or otherwise input via the user interface 220.

The user interface 220 of the controller device 200 can include inputcomponents and/or output components that are electrically connected tothe control circuitry 240. For example, the user interface 220 caninclude the display device 222 having an active area that outputsinformation to a user and buttons 224 that the user can use to provideinput. Here, the display device 222 can be used to communicate a numberof settings (e.g., user-specific dosage parameters) or menu options(e.g., options for interrupting a closed-loop delivery mode to provide amanually-initiated bolus dosage) for the infusion pump system 1. In someembodiments, the control circuitry 240 can receive input commands from auser's button selections and thereby cause the display device 222 tooutput a number of menus or program screens that show particularsettings and data. The control circuitry 240 may be programmable tocause the control circuitry 240 to change any one of a number ofsettings or modes of operation for the infusion pump system 1. In someembodiments, the control circuitry 240 can include a cable connector(e.g., a USB connection port or another data cable port) that isaccessible on an external portion of the controller housing 210. Assuch, a cable can be connected to the control circuitry 240 to upload ordownload data or program settings to the control circuitry.

Referring now to FIGS. 4A-4C, the controller device 200 of the pumpassembly 10 can be configured to receive user input triggering atemporary interruption of a closed-loop delivery mode of operations. Forexample, the user interface 220 can be employed to manually input adesired bolus dosage (e.g., in anticipation of a meal or to manuallycorrect a high blood glucose level). As shown in FIG. 4A, the user mayactivate particular buttons 224 of the user interface 220 so as toselect a particular menu option that prompts the user to input a valuefor the bolus dosage in terms of insulin units. Some examples oftemporarily interrupting the closed-loop delivery mode to provide amanually-initiated bolus dosage are explained in further detail below inconnections with FIGS. 5 and 6A-6B. Optionally, in this embodimentdepicted in FIGS. 4A-4C, the controller device 200 can receive the bolusdosage value selected by the user and determine whether the requestedbolus dosage may undesirably “stack” with previous dosages to cause anoverdose of insulin (e.g., symptoms of hypoglycemia). Thus, for example,the controller device 200 may calculate a “stacking value” accountingfor insulin previously delivered to the user during the closed-loopdelivery mode of the pump assembly 10 in addition to the requesteddosage entered by the user. In some implementations, the stacking valueis calculated by aggregating the bolus dosage requested by the usertogether with the “effective insulin-on-board” (eIOB). The eIOBcorresponds to the net amount of remaining active insulin in the user'ssystem over a selected time period immediately prior to the calculation.One non-limiting example is described below:Stacking Value=(Requested Bolus Dosage)+(eIOB).

eIOB=[Σ(Dosage_(n)*Duration Factor(t)_(n))]−Estimated Basal Rate, whereDosage_(n) represents the quantity of any insulin dosage among “n”number of dosages delivered to the user during the selected time period(“n” being any positive whole number), where Duration Factor(t)_(n),represents a factor discounting the dosage based on the amount of time“t” since its delivery, and where Estimated Basal Rate represents anestimate of the user's background insulin needs.

Due in part to pharmacokinetic effects (e.g., the time it takes forinsulin to enter the blood stream from the subcutaneous point ofdelivery) and pharmacodynamic effects (e.g., the time it takes for aconcentration of insulin in the blood to have the physiological effectof lower blood glucose level), insulin dispensed into the user's systemmay not act instantaneously, but instead may act over a period of timeto control the user's blood glucose level. As such, at any given timethe user's body may include some amount of insulin that has not yetacted. Thus, a duration factor determined as a function of time isapplied to the quantity of each dosage during the specified time periodto estimate a value of previously dispensed insulin that has not yetacted in the user's body. In some implementations, suitable durationfactors may be determined based on a duration of action profilepreloaded into the controller device 200. In some implementations,suitable duration factors may be calculated on demand by the controllerdevice 200 based on historical logs of previous dosages and bloodglucose data stored in computer memory.

As previously described, the pump controller device 200 can optionallyoperate in an open-loop mode where scheduled basal dosages of insulinare supplied in addition to user-prompted bolus dosages. The basaldelivery rate can be selected to maintain a user's blood glucose levelin a targeted range during normal activity when the user is notconsuming food items. Thus, the basal delivery rate may correspond tothe user's background insulin needs. In the open-loop delivery mode, theuser-selected bolus deliveries supplement the scheduled basal deliveriesby providing substantially larger amounts of insulin in particularcircumstances, such as when the user consumes food items, when theuser's blood glucose level increases beyond a safe limit, when theuser's blood glucose level rises faster than a threshold rate, or otherscenarios in which the blood glucose level requires a significantcorrection.

When the infusion pump system 1 operates in a closed-loop mode, however,the insulin dispensation is autonomously adjusted in response to changesin the user's blood glucose level. As such, in the closed-loop mode, theinfusion pump system 1 may not necessarily adhere to a pre-stored basalschedule (because the user's blood glucose level is changing). Thus, theuser's background insulin needs cannot simply be taken as a constant,pre-stored basal delivery rate, but the controller device 200 mayinstead approximate an “Estimated Basal Rate” based on the insulindispensations performed during the closed-loop delivery mode. Theestimated basal rate may be preloaded into the controller device orcalculated based on historical logs of previous insulin dosages and/oruser input (e.g., user input indicating a total daily dose of insulin).In some embodiments, the estimated basal rate may calculated as:

Estimated Basal Rate=Total Dose/(T*Scale Down Factor), where Total Doserepresents the quantity of insulin delivery during the time period “T,”and where Scale Down Factor represents a multiplier selected to scaledown the total dose to a fractional value that only accounts for insulindelivered to meet the user's background insulin needs. For example, ifthe time period “T” is taken as 24 hours and the scale down factor istaken as 2.0, the estimated basal rate is calculated as the total dailydose divided by 48.0, which corresponds to the hourly rate needed toprovide 50% of the total daily dose as basal insulin for fulfilling theuser's background insulin needs. In some embodiments, the scale downfactor can range from about 2.50 to about 1.50 (e.g., about 1.66).

In some embodiments, the estimated basal rate may be determined bycalculating the average basal rate outside of detectable meal times fora given time period. More specifically, the controller device 200 mayexclude insulin deliveries adjacent detected meal times from the averagebasal rate calculation. For example, the controller device 200 mayexclude insulin delivers from a predetermined time before (e.g., 0 to 45minutes) and after (e.g., 90 to 180 minutes) a detected meal from theaverage basal rate calculation. Any suitable meal-detection algorithmcan be used for determining an estimated basal rate according to theabove described technique. In some embodiments, a fuzzy-logic dosingrules matrix can be used to determine when meals have occurred. Forexample, certain cells of the matrix may be pre-set as associated withbasal or meal-time bolus insulin; and/or statistical analytics may beemployed to identify cells that tend to correspond with the onset ofglucose rise after a meal for a particular user. Further, in someembodiments, the controller device 200 may determine that a meal hastaken place based on direct scrutiny of the user's blood glucose level.For example, a rapid increase in blood glucose may signal that a meal islikely to have taken place.

In some embodiments, insulin delivers adjacent detectable exercisesessions may be excluded from the estimated basal rate calculation. Forexample, in some embodiments, activity sensors incorporated within theinfusion pump system 1 or linked via telemetry could be used to identifyexercise or elevated activity levels. Typically the need for insulin isreduced following exercise. Thus excluding insulin delivery data for aperiod of time after the detection of elevated activity would improvethe detection of underlying basal delivery. As one particular,non-limiting example, after detecting 45 minutes of activity levelsrelated to running or walking, the system could be designed to excludeinsulin deliveries from the estimated basal calculation for a period of2 to 8 hours.

As shown in FIG. 4B, if the value input by the user causes the stackingvalue to exceed a predetermined stacking threshold, the controllerdevice 200 can output an alert to the user in the form of a textualalert message provided on the display device 222 and, optionally, anaudible or vibratory alarm and a temporary illumination of theaforementioned inspection light device 230. In this example, the textualalert notifies the user of the amount eIOB and indicates that themanually entered bolus dosage is not permitted. In addition to providingthe alert, the controller device 200 may also prompt the user to take acorrective action. For example, the user can select a button 224 a,which causes the controller device 200 to respond by displaying variousmenu options to correct the non-permitted manual bolus dosage (e.g., anoption to re-enter a corrected bolus dosage and an option to initiate asuggested bolus calculation, see FIG. 4C). Alternatively, the user canselect a button 224 b indicating that the user does not wish to continuewith a manual bolus dosage, allowing the controller device 200 to cancelthe attempt to initiate a manual bolus and thereby resume closed-loopdelivery mode.

Referring now to FIG. 5, the control circuitry of an infusion pumpsystem can implement a process 500 of operating the infusion pump systemaccording to an interruptible closed-loop mode of control. Such aprocess 500, for example, can be implemented by the control circuitry240 housed in the controller device 200 of an infusion pump assembly 10(FIGS. 1-3). However, the description here is not necessarily limited toany particular infusion pump system with respect to process 500, and theprocess 500 may be implemented using, for example, an infusion pumpsystem in which the control circuitry and drive system components arehoused together in a reusable pump unit (see FIG. 7).

In operation 502, the controller device 200 delivers medicine (e.g.,insulin in this embodiment) at a dispensation rate according to aclosed-loop control protocol. As previously described, in theembodiments in which the infusion pump system is dispensing insulin,closed-loop operations facilitated by the control circuitry may causethe infusion pump system to imitate a pancreatic beta cell so that theinsulin dispensation is adjusted according to increases or decreases inthe user's blood glucose level (see FIG. 5). This type of closed-loopcontrol (often termed “artificial pancreas control”) can be executed bythe control circuitry via any suitable control algorithm (e.g., aproportional-integral-derivative (PID), fuzzy logic, or model predictivecontrol algorithm).

In operation 504, the controller device 200 can detect receipt of atrigger to initiate a user-prompted bolus dosage. Such a trigger canoccur at any time during the closed-loop delivery mode. As previouslydescribed, in some embodiments, such a trigger event may include auser's selection of a particular button (e.g., a physical button or atouchscreen button) on the user interface of the controller, which mayindicate the user's request for a manually-initiated bolus dosage. Inoperation 506, if the trigger is received (504), the controller device200 can temporarily interrupt the closed-loop delivery mode to providethe user-prompted manual bolus (see FIGS. 6A and 6B) and thenautomatically returns to the closed-loop delivery mode at operation 502.

When no trigger is detected (504), the process 500 continues in theclosed loop delivery mode. In operation 508, the pump system canreceiving blood glucose information indicative of a sensed blood glucoselevel of the user. For example, as described above, blood glucose datacan be received from a glucose monitoring device 50 in wirelesscommunication with the pump assembly 10 (or received from a bloodglucose test strip reader).

In operation 510, the sensed blood glucose level (as indicated by thereceived blood glucose data) is compared to a target blood glucose level(or otherwise compared to a target blood glucose range). In oneimplementation, one or more target blood glucose levels may be stored inmemory device 242 of the control circuitry 240. The target blood glucoselevels may correspond to one or more monitored sensory feedback signals.For instance, the target blood glucose level may vary according to theuser's food intake and/or physiological status. As one example, thememory device 242 stores data indicating at least a fasting target bloodglucose level and a postprandial target blood glucose level. In someembodiments, a target blood glucose level can be expressed as a range.In some embodiments, the target blood glucose levels can be manuallysubmitted to the controller device 200 via the user interface 220. Insome embodiments, the target blood glucose levels can be determinedstatistically or empirically by the controller device 200 as auser-specific dosage parameter based on previous iterations of aclosed-loop delivery scheme.

If operation 510 reveals that the sensed blood glucose level isdifferent from the targeted blood glucose level, the process 500continues to operation 512 so that the dispensation rate is autonomouslyadjusted according to the closed-loop control protocol. In someembodiments, the dispensation rate is adjusted according to PID controlcalculations, fuzzy logic control calculations, and/or model predictivecontrol calculations. Then, the controller device 200 returns tooperation 502 so that the medicine is dispensed at the newly adjusteddispensation rate while awaiting detection of a trigger (operation 504)and/or updated information indicative of a sensed blood glucose level(operation 508).

If operation 510 reveals that the sensed blood glucose level is notdifferent from the targeted blood glucose level, the process 500 returnsto operation 502 so that the medicine is dispensed at the previouslyimplemented dispensation rate while awaiting detection of a trigger(operation 504) and/or updated information indicative of a sensed bloodglucose level (operation 508).

As noted above, a suitable closed-loop delivery mode may also beimplemented via predictive control techniques. For example, one or morepredictive models or fuzzy-logic dosage matrices may be employed todrive the dispensation of insulin dosages based on predicted bloodglucose levels, such as described in U.S. Pat. No. 8,548,544.

In some implementations, one or more processes or specific operationsdescribed herein can be used in conjunction with types of medicationother than insulin—e.g., glucagon. The glucagon may be delivered to auser via an infusion pump device or injected using a manual syringe or asingle use injection “pen.” In some circumstances, an injectable form ofglucagon is used in emergency aid of severe hypoglycemia when the victimis unconscious or for other reasons cannot take glucose orally. Theglucagon fluid can be rapidly injected to the patient by intramuscular,intravenous or subcutaneous injection, and quickly raises the bloodglucose level of the patient.

FIG. 6A depicts a first example process 600 a for interrupting theclosed-loop delivery mode to provide a manually-initiated bolus dosage,for example, where medicine dosages (e.g., bolus dosages of insulin) arecalculated in response to a request by the user and/or suggested by thecontroller device and confirmed by the user. In some embodiments, thecontroller device 200 may implement one or more operations of theprocess 600 a to determine and suggest an insulin bolus dosage whichincludes a food offsetting component, a blood glucose correctioncomponent, and an eIOB component. The food offsetting component canrepresent an insulin bolus dosage to offset food intake data that havenot previously been offset by an earlier bolus dosage. The blood glucosecorrection component can represent an insulin bolus dosage to maintainor return the user's blood glucose level to a targeted value within apredetermined range. This component can be derived from one or moredosage parameters (e.g., insulin sensitivity and carbohydrate ratio),data indicative of a user's blood glucose level (e.g., the user'scurrent blood glucose level) and the recent rate of change in the user'sblood glucose level. As described above, the eIOB component correspondsto the net amount of remaining active insulin in the user's system overa selected time period immediately prior to the calculation. In someembodiments, the suggested bolus dosage value can be calculated based onat least two of the three components as previously described: the foodoffsetting component and/or the blood glucose correction componentcombined with the eIOB component. It should be understood from thedescription herein that the components can be contemporaneouslycalculated to provide the suggested bolus dosage value or,alternatively, calculated in discrete steps and then combined to providethe suggested bolus dosage value.

Referring in more detail to FIG. 6A, in operation 602, the user canoptionally enter data indicative of food intake (e.g., a meal that isabout to be consumed, a meal that has recently been consumed, or thelike) using the user interface 220 of the controller device 200. Inoperation 604, the controller device 200 can determine a rate of change(e.g., increase or decrease) based on the dosage history and the bloodglucose level. In operation 606, the controller device 200 determinesthe eIOB.

After the user's blood glucose information is obtained (e.g., viaoperations 602-606), in operation 608, the controller device 200 candetermine a suggested bolus dosage based on the obtained data and theuser-specific dosage parameters that were determined during theclosed-loop delivery mode. As noted above, in some embodiments, thesuggested bolus dosage value can be calculated by the controller device200 based on the eIOB component and one or both of the food offsettingcomponent and the blood glucose correction component. In suchembodiments, the food offsetting component can represent an insulinbolus dosage to offset food intake data that have not previously beenoffset by an earlier bolus dosage. The blood glucose correctioncomponent can represent an insulin bolus dosage to maintain or returnthe user's blood glucose level to a targeted value within apredetermined range. The eIOB component can take into account the netamount of remaining active insulin in the user's system over a selectedtime period immediately prior to the calculation. One non-limitingexample is described below:Suggested Bolus Dosage=(Food Offsetting Component)+(Blood GlucoseCorrection Component)−(eIOB Component).

Food Offsetting Component=(Carbohydrate Intake)*(Insulin to Carb.Ratio), where Carbohydrate Intake represents the number of grams ofcarbohydrates consumed (or to be consumed) and Insulin to Carb. Ratiorepresents a user-specific ratio (which was preferably determined andstored during the closed-loop mode during this embodiment) of the amountof insulin required to offset the consumption of a gram of carbohydrates(e.g., 14.8 U/g or the like).

Blood Glucose Correction Component=(Current Blood Glucose Level−TargetGlucose Level)*Insulin Sensitivity, where Current Blood Glucose Levelrepresents the most recent blood glucose level, Target Glucose Levelrepresents the user's desired blood glucose level, Insulin Sensitivityrepresents a user-specific value (which was preferably determined andstored during the closed-loop mode during this embodiment) thatcorrelates the number of units of insulin required to alter the user'sblood glucose level by 1 mg/dL.

eIOB Component=[Σ(Dosage_(n)*Duration Factor(t)_(n))]−Estimated BasalRate, where Dosage_(n) represents the quantity of any insulin dosageamong “n” number of dosages delivered to the user during the selectedtime period (“n” being any positive whole number), where DurationFactor(t)_(n), represents a factor discounting the dosage based on theamount of time “t” since its delivery, and where Estimated Basal Raterepresents an estimate of the user's background insulin needs.

In operation 610, the controller device 200 can determine if the useraccepts the suggested bolus dosage. For example, the user can select theuser interface button 224 corresponding to the “YES” or “NO” optionpresented on the display device 222 to accept or decline the suggestedbolus dosage. In operation 612, if the accepts the suggested bolusdosage (610), the controller device 200 can initiate delivery of thesuggested bolus dosage by the pump device 100. If the user declines thesuggested bolus dosage (610), the controller device 200 can prompt theuser for a modified dosage. In operation 614, the controller device 200can determine if the user wishes to receive a modified bolus dosage. Inoperation 616, if the user wishes to receive a modified bolus dosage(614), the controller device 200 can obtain the modified bolus dosage.For example, the user can enter a modified bolus dosage or provideadditional data that can be used to calculate a modified dosage via theuser interface 220. In operation 618, the controller device 200 caninitiate delivery of the modified bolus dosage by the pump device 100.After a suggested (612) or modified (618) bolus dosage has beeninitiated, or after the user has declined the suggested (612) andmodified dosages (618), the controller device 200 automatically returnsto the closed-loop delivery mode (see FIG. 5) at operation 620.

FIG. 6B depicts a second example process 600 b for interrupting theclosed-loop delivery mode to provide a manually-initiated bolus dosage,for example, where medicine dosages (e.g., bolus dosages of insulin) areentered manually by the user. As described above with reference to FIGS.4A-4C, the controller device 200 may determine whether the manuallyentered bolus dosage is likely to stack with previous dosagesimplemented during closed-loop operations of the infusion pump system 1to cause systems of hypoglycemia. If adverse symptoms are likely, thecontroller device 200 can alert the user and prevent delivery of therequested dosage.

Referring in more detail to FIG. 6B, in operation 650, the controllerdevice 200 causes a menu option for manually inputting a bolus dosage tobe displayed to the user via the display device 222 (see FIG. 4A). Inoperation 652, the controller device 200 receives user input indicatinga bolus dosage requested by the user. In operation 654, the controllerdevice 200 determines the eIOB. In operation 656, the controller device200 determines whether the requested bolus dosage is permissible basedon the eIOB in an attempt to prevent an overdose by stacking withprevious dosages. In some embodiments, the controller device 200determines whether the requested bolus dosage is permissible bycalculating a likely future blood glucose level resulting from thedosage, and comparing the future blood glucose level to a predeterminedminimum BG level (e.g., a BG level below which the user is likely tosuffer symptoms of hypoglycemia, such as about 60 to 70 mg/dL). Thefuture blood glucose level may be calculated using one or more suitableempirical models, predictive models (e.g., fuzzy logic matrices,classifiers, regressive predictors, neural networks and/or dynamicpredictors, such as described in U.S. Pat. No. 8,548,544), and/orblood-glucose calculators based on user-specific parameters (e.g.,insulin sensitivity). One non-limiting example is provided below:Future BG Level=(eIOB+Requested Dose)*Insulin Sensitivity

In some embodiments, the controller device 200 determines whether therequested bolus dosage is permissible by determining whether a stackingvalue, calculated as the sum of the requested bolus dosage and the eIOB(see definition describe above), is above a predetermined threshold. Thestacking threshold may be determined as the amount of insulin likely tocause the user to suffer symptoms of hypoglycemia, which may optionallybe reduced by some safety margin (e.g., 10%-20%). In some embodiments,the stacking threshold is determined based on the unique physiologicalcharacteristics of the user. For example, the stacking threshold may bemanually entered into the controller device 200 by a healthcareprofessional or determined based on historical logs of insulin dosage.For instance, the stacking threshold may be determined as the highestamount of total insulin-on-board during closed-loop operations. Asanother non-limiting example, the stacking threshold may be calculatedas:

Stacking Threshold=(Current BG Level−Minimum BG Level)/InsulinSensitivity, where Minimum BG Level represents the blood glucose levelbelow which a user may begin to experience symptoms of hypoglycemia.

In operation 658, if the requested bolus dosage is permissible (656),the controller device 200 initiates delivery of the manually enteredbolus dosage. The controller device 200 then automatically returns tothe closed-loop delivery mode (see FIG. 5) at operation 660. Inoperation 662, if the stacking requested bolus dosage is not permissible(656), the controller device 200 outputs and alert to the via the userinterface 220 of the infusion pump system 1 (see FIG. 4B). Then, inoperation 664, the controller device 200 prompts the user to enter acorrected bolus or to initiate a bolus calculation (see FIG. 4C). If theuser elects to enter a corrected bolus dosage manually (666), thecontroller device 200 returns to operation 650, where the appropriatemenu option is displayed. If the user elects to initiate a boluscalculation (668), the controller device progresses to a boluscalculator mode, such as described with reference to FIG. 6A. If theuser neither elects to enter a corrected bolus manually (666) or toinitiate a bolus calculation (668), the controller device 200 thenautomatically returns to the closed-loop delivery mode at operation 660.In some embodiments, the controller device 200 may automatically reducethe requested bolus dosage to a permissible amount without further userinput.

While the processes described above are directed to a techniqueincluding an interruptible closed-loop delivery mode. In someimplementations, the controller device may facilitate the dispensationof a bolus dosage “on top” of the closed-loop operations. So, forexample, the controller device may continue the automatic dispensationof insulin according to a suitable artificial pancreas scheme, withoutinterruption, as the user manually requests and initiates a bolusdosage. The above-described operations for safely facilitating theuser-requested bolus dosage based on eIOB may be conducted concurrentlywith the closed-loop operations. The dispensed bolus dosage can beaccounted for by the controller device in predicting a future bloodglucose level of the user in accordance with predictive closed-loopcontrol techniques.

In some implementations, a controller device (e.g., the controllerdevice 200) can operate an infusion pump system (e.g., the infusion pumpsystem) according to a closed-loop mode of control configured to accountfor glucagon medication (as an alternative to, or in addition to, theinsulin medication). The infusion pump system may be able to dispensethe glucagon directly or merely suggest to the user that a manual dosageshould be injected (e.g., via a pen applicator). In someimplementations, the controller device may interrupt closed-loopoperations to suggest and dispense (or suggest and wait for a manualinjection) a glucagon bolus in response to a determination (or aprediction, as discussed above) that the user's blood glucose level is(or is likely to be) below a certain target level. In someimplementations, the controller device may suggest and dispense theglucagon bolus “on top” (e.g., without interruption) of the closed-loopoperations. For example, the controller device may continue anymonitoring or calculating processes in the closed-loop delivery mode,and merely cease insulin dispensation, in response to a low BG leveldetermination.

The controller device in these implementations can determine a suggestedglucagon dose for the user to achieve the target blood glucose level.The suggested glucagon dose can be displayed to the user to cause theuser to confirm dispensation by the infusion pump device or manuallyadminister glucagon to achieve a blood glucose level that is proximateto the target level (or is within the target level range). If the targetblood glucose level is a range, the suggested glucagon dose can bedetermined to cause the user's blood glucose level to reach the bottomvalue of the range, to reach a mid-point value of the range, or to reachanother specified value within the range (for example, a suggestedglucagon dose can be calculated to cause the user's blood glucose levelto at least exceed a value that is 5 mg/dL greater than the bottom ofthe target blood glucose range). The controller device can use variousparameters associated with the user to determine the suggested glucagondose for the user. For example, the controller device can use the user'scurrent blood glucose level, the target blood glucose level, and theuser's glucagon sensitivity value to determine a suggested glucagon doseaccording to the following formula:Suggested Glucagon Dose=(Target BG−Current BG)/Glucagon Sensitivity

Stepping through the above equation, if, for example, the user's currentBG level is 50 mg/dL, the user's target BG level is 90 mg/dL, and theuser's glucagon sensitivity is 20 mg/dL/Unit of Glucagon, then the aboveequation would be solved as:Suggested Glucagon Dose=(90−50)/20=40/20=2 Units of Glucagon

Depending upon the concentration of the glucagon fluid, a “Unit” ofglucagon correlates to a particular number of milligrams (mg) ormicrograms (mcg) of Glucagon. For example, in this embodiment, a “Unit”of glucagon correlates to 0.4 mg of glucagon, so the suggested glucagondose of 2 Units of glucagon would be 0.8 mg of glucagon.

In some embodiments, rather than a current BG level for the user, aprojected BG level for the user can be identified based on a determinedBG level rate of change for the user and a previously identified BGlevel for the user. The controller device can then use the projected BGlevel to determine a suggested glucagon dose according to the followingformula:Suggested Glucagon Dose=(Target BG−Projected BG)/Glucagon Sensitivity

As described above, additional parameters can also be used whendetermining a suggested glucagon dosage to achieve a target BG level forthe user. For example Insulin on Board (JOB) or Total Insulin Load (TIL)values can be used in combination with an insulin sensitivity for theuser when determining a suggested glucagon dose. For example, IOB can beused to determine a suggested glucagon dose for the user according tothe formula:Suggested Glucagon Dose=(Target BG−Current BG−(IOB/insulinSensitivity))/Glucagon Sensitivity

Similarly, TIL can be used to determine a suggested glucagon dose forthe user according to the formula:Suggested Glucagon Dose=(Target BG−Current BG−(TIL/InsulinSensitivity))/Glucagon Sensitivity

Another factor that can be considered when determining the suggestedglucagon dose is a recent activity of the user. The effect of anactivity on a user can be quantified as an activity level divided by anactivity sensitivity for the user (where the activity sensitivitydefines how the user's BG level changes in response to activity).Activity level can be used to determine a suggested glucagon dose forthe user according to the formula:Suggested Glucagon Dose=(Target BG−Current BG−(Activity Level/ActivitySensitivity))/Glucagon Sensitivity

Yet another parameter that can be taken into consideration whendetermining the suggested glucagon dose for the user is Food on Board(FOB). For example, the FOB value can indicate a number of grams ofcarbohydrates ingested by the user. This value can be utilized alongwith a “carb ratio” for the user (i.e., a ratio indicating effect ofcarbohydrates on the BG level of the user). FOB can be a time sensitivefunction where food action is assumed to decay over a period of timefrom the time of ingestion. Food action may vary based on the content ofthe food, with protean and fat components having a longer time functionin comparison to high glycemic index carbohydrates, which have a veryshort time function and low glycemic index carbohydrates, which have amoderate time function. FOB can be used to determine a suggestedglucagon dose for the user according to the formula:Suggested Glucagon Dose=(Target BG−Current BG+(FOB/Carb Ratio))/GlucagonSensitivity

Another parameter that can be taken into consideration when calculatinga suggested glucagon dose is glucagon on board (GOB). The GOB value canbe, for example, received from a glucagon administration device, or beentered into a suggested glucagon dose calculator manually by a user.The GOB can be, for example, a measure of the amount of glucagon in auser's system that has not yet been processed. GOB can be used todetermine a suggested glucagon dose for the user according to theformula:Suggested Glucagon Dose=(Target BG−Current BG)/Glucagon Sensitivity−GOB

It should be understood from the teachings herein that, in someembodiments, any combination of the aforementioned parameters can betaken into consideration by the glucagon dosage calculator whencalculating a suggested glucagon dose. For example, in particularembodiments, all of these aforementioned parameters can be taken intoaccount when calculating a suggested glucagon dose:Suggested Glucagon Dose=[Target BG−Current BG−(IOB/insulinSensitivity)−(Activity Level/Activity Sensitivity)+(FOB/CarbRatio)]/Glucagon Sensitivity−GOB

(Note that TIL can be implemented instead of IOB.)

Other combinations of the above discussed parameters can be used whendetermining a suggested glucagon dose for the user. Additionalparameters could also be used in determining a suggested blood glucagondose for the user.

Referring now to FIG. 7, some embodiments of a portable infusion pumpsystem 700 suitable for use in connection with one or more of theabove-describes techniques (see, e.g., FIGS. 5, 6A and 6B) can employ areusable pump apparatus (rather than a disposable pump device aspreviously described). In such circumstances, the infusion pump system700 may comprise a reusable device that houses the control circuitry andthe pump drive system within a single housing construct. Accordingly,the pump system 700 comprises a reusable pump device that houses boththe control circuitry and the pump drive system (which may include apiston rod and one or more gears). Also, the pump system 700 can includea housing structure that defines a cavity in which a medicine cartridgecan be received (not shown in FIG. 7; refer for example to cartridge 120in FIG. 2). For example, the pump system 700 can be adapted to receive amedicine cartridge in the form of a carpule that is preloaded withinsulin or another medicine. The pump drive system can act upon thefluid cartridge to controllably dispense medicine through an infusionset 146 and into the user's tissue or vasculature. In this embodiment,the user can wear the portable pump system 700 on the user's skin underclothing or in the user's pocket while receiving the medicine dispensedthrough the infusion set 146.

The pump system 700 can also communicate with the aforementioned glucosemonitoring device 50 for the purpose of receiving data indicative of auser's blood glucose level. As shown in FIG. 7, the glucose monitoringdevice 50 can include the housing 52, the wireless communication device54, and the sensor shaft 56 (similar to the embodiment described inconnection with FIG. 1). In response to the measurements made by thesensor shaft 56, the glucose monitoring device 50 can employ thewireless communication device 54 to transmit data to a correspondingwireless communication device 747 housed in the pump system 700.

As previously described in connection with FIGS. 5, 6A and 6B, thecontrol circuitry housed in the pump system 700 may be configured tofacilitate the delivery of insulin dosages according to an interruptibleclosed-loop delivery mode of operations. That is, the closed-loopdelivery mode may be temporarily interrupted to accommodate auser-prompted bolus dosage. For example, the user may elect to manuallyenter a requested bolus dosage or to initiate a bolus dosage calculationby the pump system 700 via the user interface 720 (e.g., the displaydevice 722 and the user-interface buttons 724 a-724 e). The amount ofeIOB, which corresponds to the net amount of remaining active insulin inthe user's system over a selected time period, influences the anymanually-initiated bolus dosage (which may be calculated by the pumpsystem 700). For example, the pump system 700 may determine that amanually entered bolus dosage is likely to stack with the eIOB to causethe user to experience adverse symptoms. In this scenario, the pumpsystem 700 may provide an alert to the user, prevent dispensation of therequested dosage, and prompt the user to pursue a corrected dosage.Similarly, the pump system 700 may account for the eIOB in any dosagecalculations prompted by the user.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. A method of operating a portable insulin infusionpump system, comprising: while operating an infusion pump system toautomatically dispense insulin according to a closed-loop delivery mode,detecting a trigger event from a user to initiate a user-selected manualbolus dosage; for insulin dispensed during the closed-loop deliverymode, calculating an effective-insulin-on-board amount calculated asfollows: Effective Insulin-on-Board=[Σ(Dosage_(n)*DurationFactor(t)_(n))]−Estimated Basal Rate, where n is any positive wholenumber, and where Duration Factor(t)_(n), represents a factordiscounting the dosage based on an amount of time (t) since itsdelivery; calculating, by the infusion pump system, a calculated dosageamount of the user-selected manual bolus dosage based at least in partupon user input of an estimated number of carbohydrates to be consumedand the calculated effective-insulin-on-board amount; and dispensingfrom the infusion pump system the calculated dosage amount.
 2. Themethod of claim 1, wherein the closed-loop delivery mode causes theinfusion pump system to dispense insulin in response to feedbackinformation of a user's blood glucose level, and wherein the triggerevent comprises actuation of a user interface button indicating a user'srequest to manually initiate a bolus dispensation that is independentfrom said feedback information of the user's blood glucosecharacteristic.
 3. The method of claim 1, wherein the trigger eventcomprises actuation of a user interface button indicating a user'srequest to initiate calculation of a suggested bolus dosage by theinfusion pump system.
 4. The method of claim 1, wherein the infusionpump system comprises a controller including: a user interface displaydevice, control circuitry arranged in a controller housing and beingprogrammed to perform said calculation of the calculated dosage amountof the user-selected manual bolus dosage.
 5. The method of claim 4,wherein the infusion pump system comprises a pump device including: apump housing that houses a drive system and an insulin reservoir, thecontroller housing being removably mountable to the pump housing so thatthe controller is electrically connected to the drive system.
 6. Themethod of claim 1, wherein the calculated dosage amount of theuser-selected manual bolus dosage comprises a calculation of a suggestedbolus dosage according to the following function:Suggested Bolus Dosage=(Food Offsetting Component)+(Blood GlucoseCorrection Component)−(Effective Insulin-on-board Component).
 7. Themethod of claim 1, wherein the Estimated Basal Rate is calculatedaccording to the following function:Estimated Basal Rate=Total Dose/(T*Scale Down Factor), where T is a unitof time.
 8. A medical infusion pump system, comprising: a portable pumphousing configured to receive medicine for dispensation to a user, thepump housing at least partially containing a pump drive system todispense the medicine through a flow path to the user; and a controllerthat controls the pump drive system to: dispense the medicine from theportable pump housing according to a closed-loop delivery mode in whichthe controller autonomously provides insulin dosages to the user inresponse to feedback information of a user's blood glucose level;receive user input to initiate a user-prompted bolus dosage; calculatean effective-insulin-on-board amount calculated as follows: EffectiveInsulin-on-Board=[Σ(Dosage_(n)*Duration Factor(t)_(n))]−Estimated BasalRate, where n is any positive whole number, and where DurationFactor(t)_(n), represents a factor discounting the dosage based on anamount of time (t) since its delivery; receive a user input of a numberof an estimated number of carbohydrates to be consumed for theuser-prompted bolus dosage; calculate, by the infusion pump system, acalculated dosage amount of the user-prompted bolus dosage based uponboth the estimated number of carbohydrates to be consumed and theeffective-insulin-on-board amount; and dispense from the infusion pumpsystem the user-prompted bolus dosage.
 9. The system of claim 8, whereinthe calculated dosage amount of the user-prompted bolus dosage comprisesa calculation of a suggested bolus dosage according to the followingfunction:Suggested Bolus Dosage=(Food Offsetting Component)+(Blood GlucoseCorrection Component)−(Effective Insulin-on-board Component).
 10. Thesystem of claim 8, wherein the Estimated Basal Rate is calculatedaccording to the following function:Estimated Basal Rate=Total Dose/(T*Scale Down Factor), where T is a unitof time.
 11. The system of claim 8, wherein the input to initiate theuser-prompted bolus dosage comprises actuation of a user interfacebutton indicating a user request to manually enter a bolus dosageamount.
 12. The system of claim 8, wherein the input to initiate theuser-prompted bolus dosage comprises actuation of a user interfacebutton indicating a user request to initiate a calculation, by theinfusion pump system, of a suggested bolus dosage.
 13. The system ofclaim 8, wherein the controller comprises a user interface including adisplay device and a plurality of buttons.
 14. The system of claim 13,wherein the controller comprises a controller housing that removablyattaches to the pump housing.
 15. The system of claim 14, wherein thecontroller is electrically connected to the pump drive system when thecontroller housing is removably attached to the pump housing.
 16. Thesystem of claim 15, wherein the controller is a reusable device and thepump housing and pump drive system are disposable and nonreusable. 17.The system of claim 8, further comprising a monitoring device thatcommunicates glucose information to the controller, the glucoseinformation being indicative of a blood glucose level of the user.
 18. Aportable infusion pump system, comprising: a portable pump housingconfigured to receive medicine for dispensation to a user, the pumphousing at least partially containing a pump drive system to dispensethe medicine through a flow path to the user; control circuitry thatcontrols the pump drive system to dispense the medicine from theportable pump housing according to a closed-loop delivery mode in whichinsulin is dispensed in response to feedback information of a user'sblood glucose characteristic; and a user interface in communication withthe control circuitry and being configured to receive user input tomanually administer a bolus of insulin, wherein the control circuitry isconfigured to: calculate an effective-insulin-on-board amount calculatedas follows: Effective Insulin-on-Board=[Σ(Dosage_(n)*DurationFactor(t)_(n))]−Estimated Basal Rate, where n is any positive wholenumber, and where Duration Factor(t)_(n), represents a factordiscounting the dosage based on an amount of time (t) since itsdelivery; receive manual bolus dosage information indicative of anestimated number of carbohydrates to be consumed received by the userinterface; calculate a calculated dosage amount for the manual bolusdosage based upon the estimated number of carbohydrates to be consumedand the calculated effective-insulin-on-board amount; and dispense fromthe infusion pump system the manual bolus dosage.
 19. The system ofclaim 18, wherein the calculated dosage amount of the user-selectedmanual bolus dosage comprises a calculation of a suggested bolus dosageaccording to the following function:Suggested Bolus Dosage=(Food Offsetting Component)+(Blood GlucoseCorrection Component)−(Effective Insulin-on-board Component).
 20. Thesystem of claim 18, wherein the Estimated Basal Rate is calculatedaccording to the following function:Estimated Basal Rate=Total Dose/(T*Scale Down Factor), where T is a unitof time.